Quantaforte

GUDID 08033945934699

Intense Pulsed Light handpiece 580-950 nm HR

QUANTA SYSTEM SPA

Light-energy skin surface treatment system applicator
Primary Device ID08033945934699
NIH Device Record Key1aabb9ae-9e51-4d5d-b2c2-0bab661e8ef5
Commercial Distribution Discontinuation2018-11-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameQuantaforte
Version Model NumberOAM001907
Company DUNS436045833
Company NameQUANTA SYSTEM SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033945934699 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-01
Device Publish Date2016-08-29

On-Brand Devices [Quantaforte ]

08033945934743Laser diode handpiece 808 nm
08033945934729Nd:YAG laser handpiece 1064 nm
08033945934712Intense pulsed light handpiece 635-950 nm
08033945934705Intense Pulsed Light handpiece 580-950 nm SR
08033945934699Intense Pulsed Light handpiece 580-950 nm HR
08033945934682Intense Pulsed Light handpiece 535-950 nm
08033945934675Intense Pulsed Light handpiece 415-950 nm
080339459347362940 nm Erbium:YAg handpiece

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